Health Policy最新文献

Chimeric antigen receptor T-cell therapies (CAR-T therapies) are a type of advanced therapy medicinal product (ATMP) that belong to a new generation of personalised cancer immunotherapies. This paper compares the approval, availability and financing of CAR-T cell therapies in ten countries. It also examines the implementation of this type of ATMP within the health care system, describing the organizational elements of CAR-T therapy delivery and the challenges of ensuring equitable access to all those in need, taking a more systems-oriented view. It finds that the availability of CAR-T therapies varies across countries, reflecting the heterogeneity in the organization and financing of specialised care, particularly oncology care. Countries have been cautious in designing reimbursement models for CAR-T cell therapies, establishing limited managed entry arrangements under public payers, either based on outcomes or as an evidence development scheme to allow for the study of real-world therapeutic efficacy. The delivery model of CAR-T therapies is concentrated around existing experienced cancer centres and highlights the need for high networking and referral capacity. Some countries have transparent and systematic eligibility criteria to help ensure more equitable access to therapies. Overall, as with other pharmaceuticals, there is limited transparency in pricing, eligibility criteria and budgeting decisions in this therapeutic area.

Countries with small and/or less-resourced regulatory authorities that operate outside of a larger medical product regulatory system face a regulatory strategy dilemma. These countries may rely on foreign well-resourced regulators by recognising the regulatory decisions of large systems and following suit (regulatory reliance); alternatively, such countries may extend formal decision recognition to regulators in multiple other jurisdictions with similar oversight and public health goals, following a system which we call regulatory pluralism. In this policy comment, we discuss three potential limitations to regulatory pluralism: (i) regulatory escape, in which manufacturers exploit regulatory variation and choose the lowest regulatory threshold for their product; (ii) increased fragmentation and complexity for countries adopting this approach, which may, in turn, lead to inconsistent processes; and (iii) loss of international bargaining power in developing regulatory policies. We argue that regulatory pluralism has important long-term implications, which may not be readily apparent to policy makers opting for such an approach. We advocate for the long-term value of an alternative approach relying on greater collaboration between regulatory authorities, which may relieve administrative pressures on countries with small or less-resourced regulatory authorities, regardless of whether countries pursue a strategy of domestic regulation or regulatory pluralism.

Many studies have documented differences in maternal health outcomes across high-income countries, noting higher and growing maternal mortality in the US. However, few studies have detailed the journeys of care that may underlie or influence differences in outcomes. This study explores how maternity care entitlements and experiences vary among the US and five high-income countries, to study variations in child delivery care practices. Health systems with different organizational structure, insurance coverage and with known differences in maternal care delivery and maternal health outcomes were selected. Data was collected using a structured questionnaire, comparison of secondary data, and literature scan. We find that, while prenatal care approaches were broadly similar across all six countries, there were some important differences in maternity care provision among the comparator countries: (1) the US has more fragmented coverage during pregnancy than comparator countries (2) there were differences with regards to the main provider delivering care, the US relied primarily on physician specialists rather than midwives for prenatal care and delivery which was more common in other countries, (3) the intensity of labor and delivery care varied, particularly with regards to rates of epidural use which were highest in the US and France and lowest in Japan, and (4), there was large variation in the use of postnatal home visits to assess health and wellbeing, notably lacking in the US. The US’ greater use of specialists and more intensive labor and delivery care may partially explain higher costs of care than in comparator countries. Moreover, US maternal mortality is concentrated in the pre- and postnatal periods and thus may be related to poorer access to prenatal care and the lack of an organized, community-based approach to postnatal care. Given the increase in maternal mortality across countries, policy makers should look across countries to identify promising models of care delivery, and should consider investing in more comprehensive coverage in pre- and postnatal care.

In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As the world's first extensive legal framework on AI, it aims to boost innovation while protecting individuals against the harms of AI. Since healthcare is one of the top sectors for AI deployment, the new rules will significantly reform national policies and practices on health technology. In this article, we highlight the implications of the AI Act for the healthcare sector. We give a comprehensive overview of the new legal obligations for various healthcare stakeholders (tech developers; healthcare professionals; public health authorities). We conclude that, due to its horizontal approach, it is necessary to adopt further guidelines to address the unique needs of the healthcare sector. To this end, we make recommendations for the upcoming implementation and standardization phase.

Suicide is a global public health issue which has far-reaching impacts on individuals, families, and wider communities. Early intervention is a core pillar of policy on the prevention of suicide related deaths. However, limited mental health literacy, and negative attitudes regarding mental illness amongst the public are a barrier to early intervention. Past research has not explored mental health literacy and attitudes regarding suicide specifically. The aim of the current study was to examine mental health literacy and attitudes towards suicide in adults. 590 adults in Ireland aged 18-80 years (M = 43.24, SD = 12.6) took part in this online cross-sectional study, completing the Mental Health Literacy Scale and The Attitudes Towards Suicide Scale. Experience of suicide deaths was common among participants. Independent t-tests indicated that males had significantly lower levels of mental health literacy and more stigmatising attitudes towards suicide than females. Young adults also had lower ability to recognise mental health difficulties than older adults. Hierarchical Multiple Regressions found that mental health literacy significantly accounted for varied attitudes towards suicide in adults, particularly willingness to communicate about suicide, and beliefs that suicide is preventable. Findings are discussed in the context of informing policy-makers who are promoting early-intervention for suicide prevention.

Objectives

French dentists charge additional fees for dental prostheses. This paper aims to provide new information on the determinants of dental price setting and inform public decision-making in the context of the widespread rejection of prosthetic dental care for financial reasons. We focus on the competitive mechanism in the dental prosthetics market and measure the impact of the density of professionals and competitors' prices on the fees charged by dentists.

Methods

We use data merging from an administrative health insurance database and information from tax declarations of French dentists. We test the effect of competitor prices and competition on individual price-setting using instrumental variables. The database obtained included 29,220 dentists.

Results

Practitioners’ prices grow with competitors’ prices (+1€ in competitor prices entails an increase of + 0.37€ in the practitioner's price). Women set lower prices, and having a young child in the household predicts an increase in price of 6.8€ (p-value=0.014). Rural areas present lower fees than urban areas (+11.4€ (p value=0.000)).

Conclusion

Prosthetic prices are strategic complements that are compatible with the application of monopolistic competition in the dental care market. We encourage the regulator to develop competitive mechanisms, for example, through a public offer at moderate prices.

Introduction

A nationwide pay-for-performance (P4P) scheme was introduced in the Netherlands between 2018 and 2023 to incentivize appropriate prescribing in general practice. Appropriate prescribing was operationalised as adherence to prescription formularies and measured based on electronic health records (EHR) data. We evaluated this P4P scheme from a learning health systems perspective.

Methods

We conducted semi-structured interviews with 15 participants representing stakeholders of the scheme: general practitioners (GPs), health insurers, pharmacists, EHR suppliers and formulary committees. We used a thematic approach for data analysis.

Results

Using EHR data showed several benefits, but lack of uniformity of EHR systems hindered consistent measurements. Specific indicators were favoured over general indicators as they allow GPs to have more control over their performance. Most participants emphasized the need for GPs to jointly reflect on their performance. Communication to GPs appeared to be challenging. Partly because of these challenges, impact of the scheme on prescribing behaviour was perceived as limited. However, several unexpected positive effects of the scheme were mentioned, such as better EHR recording habits.

Conclusions

This study identified benefits and challenges useful for future P4P schemes in promoting appropriate care with EHR data. Enhancing uniformity in EHR systems is crucial for more consistent quality measurements. Future P4P schemes should focus on high-quality feedback, peer-to-peer learning and establish a single point of communication for healthcare providers.

The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies. In response, France has established Early Access Programs to expedite patient access to medical devices. This paper looks at three of these Early Access Programs for medical devices. Innovation Funding, introduced in its final version in 2015, provides temporary coverage for innovative devices and facilitates data collection for informed funding decisions. Transitional Coverage (PECT), established in 2021, targets CE-marked devices for rare or serious conditions. Transitional coverage for digital health applications (PECAN), introduced in 2022, covers digital medical devices, either therapeutic or for patient monitoring. Innovation funding has been granted to 16 technologies out of 35 applications (46%) since 2015. 6 technologies out of 11 (64%) applications benefit from PECT. PECAN, in its first year, has granted a telemonitoring solution with a favourable opinion. The French experience could provide valuable lessons for the development of a harmonised European framework to ensure that innovative medical technologies benefit those who need them, while maintaining high safety standards.

Most research on health care equity focuses on accessing services, with less attention given to how revenue is collected to pay for a country's health care bill. This article examines the progressivity of revenue collection among publicly funded sources: income taxes, social insurance (often in the form of payroll) taxes, and consumption taxes (e.g., value-added taxes). We develop methodology to derive a qualitative index that rates each of 29 high-income countries as to its progressivity or regressivity for each of the three sources of revenue. A variety of data sources are employed, some from secondary data sources and other from country representatives of the Health Systems and Policy Monitor of the European Observatory on Health Systems and Policies. We found that countries with more progressive income tax systems used more income-based tax brackets and had larger differences in marginal tax rates between the brackets. The more progressive social insurance revenue collection systems did not have an upper income cap and exempted poorer persons or reduced their contributions. The only pattern regarding consumption taxes was that countries that exhibited the fewest overall income inequalities tended to have least regressive consumption tax policies. The article also provides several examples from the sample of countries on ways to make public revenue financing of health care more progressive.